Protecting the Public

There have been some victories in the fight against counterfeit and gray market drugs. After admitting he distributed adulterated and counterfeit drugs, James Newcomb of La Jolla, CA, received a 24-month prison sentence from the US District Court for the Eastern District of Missouri. As part of the February 2012 plea deal, he also forfeited $1.4 million and a Land Rover (1).

Legal requirements

Hallie Forcinio

The US Congress, however, wants harsher punishment for offenses involving counterfeit drugs. Under the FDA Safety and Innovation Act, signed by President Obama in July 2012, the Attorney General shall give increased priority to efforts to investigate and prosecute these criminals. In addition, the US Sentencing Commission is to consider increased penalties for drug counterfeiting (2).

Meanwhile, regulators worldwide are working to protect consumers. In the European Union, the Falsified Medicines Directive 2011/62/EU takes effect on Jan. 2, 2013 (3). The Directive requires authentication features on individual prescription-drug packs to enable verification throughout the supply chain. It also strengthens requirements for control and inspection of manufacturers of active substances. Manufacturers also must report any suspicion of falsified medicines. Other provisions give penalties for the manufacturing, distribution, import, and export of falsified medicinal products and point out the dangers associated with sale of medicines via the Internet.

Regulatory initiatives

With a significant percentage of medicines purchased from Internet sites found to be counterfeit, FDA has embarked on a public education campaign, BeSafeRx: Know Your Online Pharmacy (4).

Another tool used by FDA is its October 2011 Guidance for Industry: Incorporation of Physical-Chemical Identifiers into Solid Oral Dosage Form Drug Products for Anticounterfeiting (5). FDA is also training field agents in the use of a handheld device to check for counterfeit products and packaging arriving at ports of entry. The CD3 (Counterfeit Detection Device #3) emits light in 10 wavelengths to check API and drug samples against stored scans. It also detects package tampering.

Other organizations are hard at work too. The World Health Organization’s (WHO) Working Group of Member States on Substandard/Spurious/Falsely-Labelled Falsified/Counterfeit Medical Products takes a three-pronged approach: education, norms and standards, and technical support to countries (6). WHO also supports the International Medical Products Anti-Counterfeiting Taskforce, a group it launched in 2006 with a wide range of partners including international organizations, nongovernmental organizations, enforcement agencies, pharmaceutical manufacturers’ associations, and drug and regulatory authorities.